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Leading BioSciences Receives IND Clearance for Phase 2 COVID-19 Study

CARLSBAD, Calif., May 15, 2020 (GLOBE NEWSWIRE) -- Leading BioSciences, Inc. (LBS), a drug development company focused on improving human health through therapeutic protection of the intestinal mucosal barrier, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a phase 2 study of its lead investigational drug, LB1148 for the “treatment of pulmonary dysfunction associated with COVID-19 pneumonia.” The study will include 120 hospitalized adult patients with respiratory dysfunction due to COVID-19.

The primary objective of this study is to determine whether oral/enteral administration of liquid LB1148 will impact disease progression in hospitalized patients with moderate-to-severe COVID-19 infection. The primary endpoint is the proportion of subjects alive and free of respiratory failure at Day 28. Respiratory failure is defined as a requirement for high-flow oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Currently the company is collaborating with multiple hospitals throughout the United States, including some that had been participating in the Company’s other clinical trials with the investigational drug LB1148. These hospitals therefore have experience with LB1148 and can administer the drug under the new IND to patients who test positive for SARS-Cov-2 and develop pulmonary dysfunction. Further, the study protocol has been approved by a central Investigational Review Board (IRB) to proceed with patient enrollment.

“As large numbers of patients continue to become severely ill across the globe, this IND represents an important step forward in development of new treatments for patients with COVID-19. Today, critically ill COVID-19 patients have few options but to be placed on a ventilator with palliative care. Statistics have demonstrated this is woefully inadequate for the many patients who will die without alternatives. Practitioners need more therapeutic options to improve patient outcomes and reduce the number of days patients require supportive care,” commented Tom Hallam, Ph.D., CEO of Leading Biosciences. “This IND clearance now gives us the means to test LB1148 in patients with COVID-19-related respiratory complications and hopefully to improve patient outcomes.”

LB1148 is a novel oral/enteral liquid formulation of the well-characterized protease inhibitor traexamic acid (TXA) designed to preserve the integrity of the GI tract and improve organ function in patients. As a broad-spectrum protease inhibitor, LB1148 is being tested to improve COVID-19 outcomes by protecting organs from damage by proteases leaking from compromised mucosal barrier that can lead to acute respiratory distress syndrome (ARDS). Currently under development to treat organ dysfunction and reverse lethal complications of organ dysfunction associated with septic shock and major surgery, it is designed to inhibit digestive enzyme activity and preserve gut integrity during intestinal distress (e.g., shock, infections, and surgeries). In previous clinical studies, LB1148 has demonstrated safety and improved GI function following major surgery. TXA formulations have been administered to more than 40,000 patients worldwide and have demonstrated an acceptable safety profile.

Rationale for Investigating LB1148 in COVID-19 Pneumonia

A normal intestine has a sealed mucosal epithelial barrier that contains luminal contents. When the oxygen supply to the intestine is disrupted by respiratory disfunction or shock, the mucosal epithelial barrier becomes compromised and the contents in the lumen can penetrate across the barrier. These contents, especially the digestive proteases, can destroy tissues and damage capillaries resulting in microhemorrhage formation. Once proteases are in the circulation the resulting downstream consequences can lead to acute respiratory dysfunction. As COVID-19 patients frequently experience respiratory dysfunction concurrent with GI symptoms, it is likely that many of the most severe outcomes of this disease are caused or exacerbated by a loss of intestinal barrier integrity. Further, the high density and distribution of the ACE2 and TMPRSS2 receptors on the enterocytes of the gut mucosal barrier facilitates widespread GI infection of the virus. LB1148 may prevent the disruption of the mucosal layer and minimize luminal contents from entering the wall of the intestine and systemic circulation during COVID-19 mucosal barrier disruption.

LB1148 is a patent-protected formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases that can cause a range of serious complications and organ dysfunction if they escape the GI tract through a compromised mucosal barrier. By inhibiting the activity of digestive proteases, LB1148 has the potential to prevent damage to GI tissues, speed the return of GI function and shorten patients’ post-surgery stay in the ICU and hospital. This could substantially reduce the burden on the healthcare system, based upon the average cost of both ICU and hospital stays following cardiovascular surgery. LB1148 has not been approved for use in this or any indication, nor has it been deemed by FDA as “safe’ for use in this or any patient population.

About Leading BioSciences

Leading BioSciences is developing novel therapeutics designed to improve human health through therapeutic protection of the Gastrobiome™. The Company’s initial focus is combatting the interruption of GI function (ileus) following major surgery to reduce recovery times and shorten patients’ length of stay in the hospital. Additionally, the company believes that its investigational therapies have the potential to prevent the formation of post-operative adhesions (reducing hospital re-admissions and additional surgeries), as well as to address the myriad of health conditions and complications associated with chronic disruption of the intestinal mucosal barrier.